Consistency Against LoT
Introduction
Figures are an important part of a study submission to the regulatory authorities, and contain graphic information regarding the data of a study. Besides the graph itself, figures also contain titles, number and source, the same as tables and listings. This information should be equal to the one presented in the LoT.
Purpose
Verify the consistency between LoT file and table/listing of:
- Number (drug only)
- Title
- Source
The identification key is the file name
Applicability
Inclusion conditions
- Figures in PDF format
- LoT
Exclusion
- Table, Listing, Adam, Mockshell
Discrepancies
- Title mismatch
- Footnotes mismatch
- Source data mismatch
- File missing in mock
- File appears multiple times in mock
Discrepancy Example
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